Haematology Analytical Performance Specifications
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Measurand | Lower limit | Upper limit |
---|---|---|
WCC | + or - 0.5 ≤ 5.0 x109/L | + or - 10% > 5.0 x109/L |
RCC | + or - 0.2 ≤ 2.0 x1012/L | + or - 10% > 2.0 x1012/L |
Hb | + or - 5 ≤ 100 g/L | + or - 5% > 100 g/L |
Hct | + or - 0.04 ≤ 0.20 | + or - 20% > 0.20 |
MCV | + or - 5 ≤ 50 fL | + or - 10% > 50 fL |
MCH | + or - 2 ≤ 20 pg | + or - 10% > 20 pg |
MCHC | + or -30 ≤ 300 g/L | + or - 10% > 300 g/L |
RDW-CV | + or - 2 ≤ 10% | + or - 20% > 10% |
PLT | + or - 25 ≤ 100 x109/L | + or - 25% > 100 x109/L |
MPV | + or - 2 ≤ 10 fL | + or - 20% > 10 fL |
Measurand | Lower limit | Upper limit |
---|---|---|
PT | + or -2.0 ≤ 10.0 sec | + or - 20% > 10.0 sec |
INR/POC INR | + or - 0.3 ≤ 2.0 ratio | + or - 15% > 2.0 ratio |
APTT | + or - 10 ≤ 40 sec | + or - 25% > 40 sec |
Fibrinogen | + or - 0.20 ≤ 1.0 g/L | + or - 25% > 1.0 g/L |
Thrombin Time | + or - 3 ≤ 12 sec | + or - 25% > 12 sec |
Factor II, V, VII, VIII, IX, X, XI, XII | + or - 3 ≤ 10 IU/dL | + or - 30% > 10 IU/dL |
D-Dimer (Automated) | + or - 0.25 ≤ 0.50 DD mg/L | + or - 50% > 0.50 DD mg/L |
D-Dimer (Automated) | + or - 0.5 ≤ 1.0 FEU mg/L | + or - 50% > 1.00 FEU mg/L |
Measurand | Lower limit | Upper limit |
---|---|---|
Hb A2 | + or - 0.3 ≤ 2.0% | + or - 10% > 2.0% |
Hb F | + or - 0.5 ≤ 1.50% | + or - 30% > 1.50% |
Hb Variant | + or - 4 ≤ 20% | + or - 20% > 20% |
Measurand | Lower limit | Upper limit |
---|---|---|
WCC | + or - 0.5 ≤ 5.0 x109/L | + or - 10% > 5.0 x109/L |
Neutrophils/Granulocytes | + or - 1.0 ≤ 10.0% | + or - 10% > 10.0% |
Lymphocytes | + or - 2.0 ≤ 10.0% | + or - 20% > 10.0% |
Monos/Eosinos/Basos/LUC/IG | + or - 3.0 ≤ 10.0% | + or - 30% > 10.0% |
Measurand | Lower limit | Upper limit |
---|---|---|
APTT | + or - 9.0 ≤ 30 sec | + or - 30% >30 sec |
APTT Screen Ratio | + or - 0.3 ≤ 0.9 ratio | + or - 30% > 0.9 ratio |
DRVVT screen | + or - 9.0 ≤ 30 sec | + or - 30% > 30 sec |
DRVVT screen ratio | + or - 0.3 ≤ 0.9 ratio | + or - 30% > 0.9 ratio |
Measurand | Lower limit | Upper limit |
---|---|---|
Protein C functional | + or - 12 ≤ 60% | + or - 20% > 60% |
Protein S Total Antigen | + or - 10 ≤ 40% | + or - 25% > 40% |
Protein S Free Antigen | + or - 10 ≤ 40% | + or - 25% > 40% |
Protein S Free Functional | + or - 10 ≤ 40% | + or - 25% > 40% |
AT Functional | + or - 10 ≤ 40% | + or - 25% > 40% |
Measurand | Lower limit | Upper limit |
---|---|---|
APCR APTT, APCR APTT V, APCR RVVT, APCR RVVT V, APCR Staclot | Assessed on interpretation | Assessed on interpretation |
Measurand | Lower limit | Upper limit |
---|---|---|
FVIII:C | + or - 3 ≤ 10% | + or - 30% > 10% |
VWF:Ag | + or - 3 ≤ 10% | + or - 30% > 10% |
VWF:RCo | + or - 4 ≤ 10% | + or - 40% > 10% |
VWF:CB | + or - 4 ≤ 10% | + or - 40% > 10% |
VWF:Activity | + or - 4 ≤ 10% | + or - 40% > 10% |
Measurand | Lower limit | Upper limit |
---|---|---|
Inhibitor level BU | Assessed on interpretation | Assessed on interpretation |
Measurand | Lower limit | Upper limit |
---|---|---|
Closure time | Assessed on interpretation | Assessed on interpretation |
Measurand | Lower limit | Upper limit |
---|---|---|
APTT | + or - 10 ≤ 40 sec | + or - 25% > 40 sec |
Anti Xa | + or - 0.1 ≤ 0.4 U/mL | + or - 25% > 0.4 U/mL |
Measurand | Lower limit | Upper limit |
---|---|---|
DTI | + or - 25 ≤ 100 ng/mL | + or - 25% > 100 ng/mL |
Measurand | Lower limit | Upper limit |
---|---|---|
Anti Xa | + or - 25 ≤ 100 ng/mL | + or - 25% > 100 ng/mL |
Measurand | Lower limit | Upper limit |
---|---|---|
Anti Xa | + or - 25 ≤ 100 ng/mL | + or - 25% > 100 ng/mL |
Measurand | Lower limit | Upper limit |
---|---|---|
Factor XIII | Assessment on diagnostic interpretation | Assessment on diagnostic interpretation |
Measurand | Lower limit | Upper limit |
---|---|---|
G6PD assay | + or - 3.0 ≤ 10.0 U/g Hb | + or - 30% > 10.0 U/g Hb |
Measurand | Lower limit | Upper limit |
---|---|---|
ESR | + or - 3.0 ≤ 10.0 mm/hr | + or - 30% > 10.0 mm/hr |
Measurand | Lower limit | Upper limit |
---|---|---|
Percentage | + or - 0.6 ≤ 2.0% | + or - 30% > 2.0% |
Absolute count | + or - 21.0 ≤ 70.0 | + or - 30% > 70.0 x109/L |
Measurand | Lower limit | Upper limit |
---|---|---|
Percentage | + or - 1.0 ≤ 10.0% | + or - 10% > 10.0% |
Absolute count | + or - 10 ≤ 100 | + or - 10% > 100 x109/L |
Measurand | Lower limit | Upper limit |
---|---|---|
Clotting Times | Assessment under review | Assessment under review |
Measurand | Lower limit | Upper limit |
---|---|---|
Clotting Times | Assessment under review | Assessment under review |
Measurand | Lower limit | Upper limit |
---|---|---|
%CD34 | + or - 0.05 ≤ 0.20% | + or - 25% > 0.20% |
Total CD34 | + or -5 ≤ 20.0 | + or - 25% > 20.0 μL |